- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07854171
The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease (CHD)
The Effect of Telerehabilitation-based Functional Inspiratory Muscle Training on Respiratory Function, Muscle Strength, Exercise Capacity, and Quality of Life in Children With Congenital Heart Disease
This study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with congenital heart disease.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Congenital heart disease (CHD) is a common condition in newborns. As a congenital disorder, CHD is the leading cause of infant mortality. Recent advances in medical treatment and surgical procedures have improved survival rates among children with CHD. However, despite these developments, children with CHD may still exhibit muscle weakness, physical inactivity, reduced performance in activities of daily living, and a decline in health-related quality of life. Therefore, this study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with CHD.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gülşah Barğı, Assoc Prof
- Numer telefonu: +90 232 299 0739
- E-mail: gulsahbargi35@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Berfin Kişin Sarıoğlu, MSc, PT
- Numer telefonu: +905394671464
- E-mail: kisinberfin@gmail.com
Lokalizacje studiów
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Izmir, Turcja (Türkiye), 35140
- Izmir Democracy University
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Kontakt:
- Gülşah Barğı, Assoc Prof
- Numer telefonu: +905317938766
- E-mail: gulsah.bargi@idu.edu.tr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Having been diagnosed with CHD,
- Being between 8 and 18 years of age,
- Being in stage I, II, or III according to the New York Heart Association (NYHA) classification,
- Having a stable clinical condition,
- Volunteering to participate in the study.
Exclusion Criteria:
- Having a history of any orthopedic or neurological disease that could interfere with the tests and exercises to be performed,
- Having a history of any mental or psychological disease that could interfere with the tests and exercises to be performed,
- Having any infection that could interfere with the tests and exercises to be performed,
- Having undergone cardiac surgery within the last 6 months,
- Having a contraindication for the exercise test.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: İntervention group
The telerehabilitation program will last a total of 8 weeks and will consist of two parts: 4 weeks of inspiratory muscle training and 4 weeks of functional inspiratory muscle training. The training program will be held every day of the week, with 3 of those days conducted under the supervision of a physiotherapist. |
Moderate-intensity basic inspiratory muscle training will be provided using a threshold pressure loading device (POWERBreathe) for the first four weeks, starting at 30% of MIP and gradually increasing to 50% depending on the participant's tolerance. The training will be conducted twice daily, 15 minutes in the morning and 15 minutes in the evening, for a total of 30 minutes. With the device, the patient will perform 5-10 deep breathing cycles, then remove the device and perform 3-5 calm breaths to control their breathing. At the end of each day, the physiotherapist will communicate with the patients to assess their progress in the exercise and record it in the exercise log. Following basic IMT, simultaneous exercises (wall plank, wall lateral bridge, wall bridge, shoulder flexion/abduction, elbow flexion, trunk rotation, squat-stand, standing leg raise, walking) will be performed for 4 weeks. Abdominal muscle activation will be taught at the beginning of the training, and functional exercises, paying attention to abdominal stabilization, will continue throughout the training sessions. Moderate intensity IMT will be applied, starting from 30% of the MIP and increasing up to 50% depending on the participant's tolerance. While using the device, the patient will take 5-10 deep breaths and simultaneously perform the functional exercises in sequence, each with 5-10 repetitions/sets (1-3 sets per day). Then, they will remove the device from their mouth and practice breath control by taking 3-5 calm breaths. Exercises that the patient cannot perform will be recorded. |
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Brak interwencji: Controlled group
Participants in this group will continue with their routine daily lives. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Inspiratory Muscle Strength
Ramy czasowe: Baseline and after 8-week
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Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded. |
Baseline and after 8-week
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Expiratory Muscle Strength
Ramy czasowe: Baseline and after 8-week
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Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded. |
Baseline and after 8-week
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of Life Score
Ramy czasowe: Baseline and after 8-week
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The Pediatric Quality of Life Inventory 3.0 Cardiac Module will be assessed using Turkish versions of the 8-12 and 13-18 year old child and parent forms. A minimum score of 0 and a maximum score of 100 can be obtained on the scale; a higher score indicates a higher quality of life. |
Baseline and after 8-week
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Exercise Capacity measurement
Ramy czasowe: Baseline and after 8-week
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Maximal exercise capacity will be assessed using the Incremental Shuttle Walk Test. The number of shuttles completed after the test will be recorded. |
Baseline and after 8-week
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Measurement of Functional Capacity
Ramy czasowe: Baseline and after 8-week
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Functional capacity will be assessed using the 1-minute sit-to-stand test, and the number of sit-to-stand repetitions performed in one minute will be recorded. |
Baseline and after 8-week
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Grip strength measurement
Ramy czasowe: Baseline and after 8-week
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Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer. |
Baseline and after 8-week
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Measurement of Back and Leg Strength
Ramy czasowe: Baseline and after 8-week
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Back and leg strength will be measured using a Saehan standard platform back-leg-chest dynamometer. The best value recorded from the dynamometer after three trials will be noted in kilograms. |
Baseline and after 8-week
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Forced vital capacity (FVC)
Ramy czasowe: Baseline and after 8-week
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Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. |
Baseline and after 8-week
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Forced expiratory volume in the first second (FEV1)
Ramy czasowe: Baseline and after 8-week
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Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. |
Baseline and after 8-week
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FEV1/FVC
Ramy czasowe: Baseline and after 8-week
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Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. |
Baseline and after 8-week
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Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Ramy czasowe: Baseline and after 8-week
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Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. |
Baseline and after 8-week
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Peak flow rate (PEF)
Ramy czasowe: Baseline and after 8-week
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Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. |
Baseline and after 8-week
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- Główny śledczy: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
- Główny śledczy: Sema Savcı, Prof, Acibadem University
- Główny śledczy: Mustafa Kır, Prof, Dokuz Eylul University
Publikacje i pomocne linki
Publikacje ogólne
- Arnouts EC, Drysdale ND, Gerstner Saucedo J, Gonzalez de Alba C, Malone LJ, Fonseca B, DiMaria MV, Browne LP, Barker AJ. Examination of elevated myocardial extracellular volume and exercise capacity in pediatric Fontan patients at moderate altitude. Pediatr Radiol. 2026 Sep;56(10):2260-2271. doi: 10.1007/s00247-026-06675-2. Epub 2026 Jun 3.
- Haas SD, van der Hulst AE, Widyanti AP, van Schuppen J, Oosterlaan J, van den Aardweg JG, Ten Harkel ADJ, Kuipers IM, Blom NA. Cardiorespiratory fitness in children with surgically corrected congenital heart disease: Exercise testing profiles and biventricular function. Am Heart J. 2026 Aug 26;303:107590. doi: 10.1016/j.ahj.2026.107590. Online ahead of print.
- Dorobantu DM, van de Bruaene A, Budts W, Cifra B, Friedberg MK, Fritsch P, Khoury M, Muller J, Opotowsky A, Sanatani S, Williams C, Hansmann G, Pieles GE. Sports and Supervised Exercise Programmes for Children and Young Adults with Pulmonary Hypertension. 2026 Consensus Statement from the European Pediatric Pulmonary Vascular Disease Network (EPPVDN) and the Association for European Paediatric and Congenital Cardiology (AEPC). J Heart Lung Transplant. 2026 Jul 29:S1053-2498(26)02015-2. doi: 10.1016/j.healun.2026.07.026. Online ahead of print.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Congenital Heart Disease
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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